Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

Pfizer

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Other: Placebo; Drug: AAB-003 (PF-05236812)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193608

B2601001

3245K1-1000 (Other Identifier)

Details and patient eligibility

About

This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks.

Enrollment: 88 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease
• Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
• Caregiver will participate and be able to attend clinic visits with patient

Exclusion criteria

• Significant neurological disease other than Alzheimer's Disease
• Major psychiatric disorder
• Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
• Women of childbearing potential

Trial design

88 participants in 6 patient groups, including a placebo group

0.5 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

1 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

2 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

4 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

8 mg/kg AAB-003

Experimental group

Treatment:

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Drug: AAB-003 (PF-05236812)

Placebo

Placebo Comparator group

Treatment:

Other: Placebo